BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1904834 · Received November 22, 2010

    Report

    Report Number
    9611451-2010-00701
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 4, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT CHAMBER WAS PRESSURE TESTED, SUBMERGED IN A WATER BATH AND THE BASE THICKNESS WAS GAUGED. RESULTS: THE PRESSURE DROP OF THE CHAMBER WAS OUT OF SPECIFICATION FOR THIS PRODUCT. THE WATER BATH TEST REVEALED THE LEAK TO BE BETWEEN THE CHAMBER DOME AND BASE. GAUGING OF THE BASE THICKNESS REVEALED THE BASE TO BE OUT OF SPECIFICATION AS FULL INSERTION WAS UNSUCCESSFUL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200CMH20 FOLLOWING THE MANUFACTURING PROCESS, TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. IN THIS CASE, THE BASE OF THE CHAMBER DOME HAS NOT BEEN ROLLED CORRECTLY. THE CHAMBER PASSED BOTH THE MANUFACTURING AND CUSTOMER PRE-USE PRESSURE TESTS, THEREFORE, IT IS LIKELY THAT THE HEATING OF THE ALUMINIUM BASE HAS CAUSED THE INADEQUATE ROLLING TO BECOME EVIDENT, LEADING TO LEAKING. FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER SPECIFY TO THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT", TO REFRAIN FROM USING THE CHAMBER IF IT HAS BEEN DROPPED AND "TO SET THE APPROPRIATE VENTILATOR ALARMS" IN THE EVENT A LEAK OCCURS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT THE CHAMBER OF AN MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 100111

    Patients

    Seq Age Sex Outcome Treatment
    1